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NCT01376349 · ADVERSE EVENTS

Adverse events

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms · Source last updated 2019-02-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%

All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I: Low Dose DHEA

Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

3 / 14791 / 147Not reported / Not reported
Arm II: High Dose DHEA

Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

7 / 148105 / 148Not reported / Not reported
Arm III: Placebo

Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

4 / 14793 / 147Not reported / Not reported
Optional Continuation Phase

Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study. 94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.

0 / 9428 / 94Not reported / Not reported

Group identifiers: EG000: Arm I: Low Dose DHEA · EG001: Arm II: High Dose DHEA · EG002: Arm III: Placebo · EG003: Optional Continuation Phase

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Bladder infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Breast infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Vaginal infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Investigations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Headache
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Breast pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Voice alteration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Hirsutism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Rash acneiform

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Small intestine ulcer
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Flu like symptoms
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Irritability
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Non-cardiac chest pain
Complete source fields
description
All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
event Groups
  1. description
    Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    EG000
    other Num Affected
    91
    other Num At Risk
    147
    serious Num Affected
    3
    serious Num At Risk
    147
    title
    Arm I: Low Dose DHEA
  2. description
    Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    148
    serious Num Affected
    7
    serious Num At Risk
    148
    title
    Arm II: High Dose DHEA
  3. description
    Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    EG002
    other Num Affected
    93
    other Num At Risk
    147
    serious Num Affected
    4
    serious Num At Risk
    147
    title
    Arm III: Placebo
  4. description
    Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study. 94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.
    id
    EG003
    other Num Affected
    28
    other Num At Risk
    94
    serious Num Affected
    0
    serious Num At Risk
    94
    title
    Optional Continuation Phase
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Ear pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Small intestine ulcer
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Flu like symptoms
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Irritability
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Non-cardiac chest pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Bladder infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Breast infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Vaginal infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Investigations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      147
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Headache
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Breast pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      147
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Voice alteration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Hirsutism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      147
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      147
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
      num Events
      0
    term
    Rash acneiform

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Preserved source evidence · Not medical advice